Variability in Institutional Board Review for a Multisite Assessment of Resident Professionalism

被引：4
|
作者：
Linden, Judith A. [1 ,6 ]
Schneider, Jeffrey I. [2 ,6 ,7 ]
Cotter, Andrea [3 ,8 ]
Drexel, Sabrina [1 ,8 ]
Frosch, Emily [9 ]
Martin, Niels D. [10 ]
Canavan, Colleen [11 ]
Holtman, Matthew [11 ]
Mitchell, Patricia M. [4 ,6 ]
Feldman, James A. [5 ,6 ]
机构：
[1] Boston Med Ctr, Dept Emergency Med, Educ, Boston, MA USA
[2] Boston Med Ctr, Grad Med Educ Comm, Boston, MA USA
[3] Boston Med Ctr, Emergency Med, Boston, MA USA
[4] Boston Med Ctr, Dept Emergency Med, Res Operat, Boston, MA USA
[5] Boston Med Ctr, Dept Emergency Med, 1 Boston Med Ctr Pl,Dowling 1 South, Boston, MA 02118 USA
[6] Boston Univ, Sch Med, Emergency Med, Boston, MA 02215 USA
[7] Boston Univ, Sch Med, Grad Med Educ & Designated Inst Official DIO, Boston, MA 02215 USA
[8] Boston Univ, Sch Med, Boston, MA 02215 USA
[9] Johns Hopkins Univ, Sch Med, Dept Psychiat & Behav Sci, Div Child & Adolescent Psychiat, Baltimore, MD USA
[10] Thomas Jefferson Univ, Philadelphia, PA 19107 USA
[11] Natl Board Med Examiners, Philadelphia, PA USA
来源：
JOURNAL OF EMPIRICAL RESEARCH ON HUMAN RESEARCH ETHICS | 2019年 / 14卷 / 02期
关键词：
research ethics committees; institutional review boards; graduate medical education; medical professionalism; MEDICAL-EDUCATION RESEARCH; MINIMAL-RISK; DECISIONS; RESPONSES; STANDARD; POLICY;
D O I：
10.1177/1556264619831895
中图分类号：
B82 [伦理学（道德学）];
学科分类号：
摘要：
Residents serve as both trainees and employees and can be considered potentially vulnerable research participants. This can lead to variation in the institutional review board (IRB) review. We studied sites participating in the Assessment of Professional Behaviors Study sponsored by the National Board of Medical Examiners (2009-2011). Of the 19 sites, all but one were university affiliated. IRB review varied; 2/19 did not submit to a local IRB, 4/17 (23%) were exempt, 11/17 (65%) were expedited, and 2/17 (12%) required full Board review; 12/17 (71%) required written informed consent. The interval from submission to approval was 1 to 2 months (8/17); the range was 1 to 7 months. Although most stated there were no major barriers to approval, the most common concern was resident coercion and loss of confidentiality. Local IRB review of this educational research study varied.
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页码：117 / 125
页数：9
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